OSMITROL 20% IN WATER IN PLASTIC CONTAINERmannitol

FDA approved the original new drug application for OSMITROL 20% IN WATER IN PLASTIC CONTAINER on June 8, 1964, sponsored by BAXTER HLTHCARE. FDA has approved 1 efficacy supplement on the application since, the most recent on November 15, 2018.

Application

NDA013684

Sponsor

BAXTER HLTHCARE

Original approval

June 8, 1964

Review

standard review

Submission class

Type 5 - New Formulation or New Manufacturer

Active ingredient

mannitol

Browse every approval whose brand starts with O, or the complete response letters FDA has published — the applications it did not approve.

Products under this application

Approved efficacy supplements

An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.

FDA records other approved supplements on this application, by the class code it assigns them: Manufacturing (CMC) 61 · Labeling 13 · Supplement 2. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.

Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.

Other approvals to BAXTER HLTHCARE

• December 24, 2008NEXTERONENDA022325
• August 5, 2008CEFEPIME IN PLASTIC CONTAINERNDA050817
• March 21, 2002MESNEXNDA020855
• August 26, 1998PROSOL 20% SULFITE FREE IN PLASTIC CONTAINERNDA020849
• September 29, 1997CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINERNDA020734
• March 26, 1997CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINERNDA020678